RecruitingNCT06507579

Hydra Registry - UK

Prospective Observational Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Sponsor

Sahajanand Medical Technologies Limited

Enrollment

250 participants

Start Date

Jul 11, 2024

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Stenosis

Summary

The study will evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) using the Hydra transcatheter aortic heart valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. This will include an evaluation of the preservation of coronary access post implant by attempting to selectively engage both the right and left coronary arteries through standardised angiographic views. The study will also examine the utility of 72 hours of post discharge remote ambulatory continuous electrocardiogram (ECG) monitoring using the novel Checkpoint Cardio System where it is clinically appropriate.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Hydra transcatheter aortic valve (THV) series for people with aortic valve stenosis. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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